Ignite Creation Date:
2024-05-05 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00658931
Status:
UNKNOWN
Last Update Posted:
2010-02-12
First Post:
2008-04-10
Brief Title:
Cymbalta for Depression as a Complication of Bereavement
Sponsor:
Jefferson Clinic PC
Organization:
Jefferson Clinic PC
Study Overview
Official Title:
Cymbalta for Depression as a Complication of Bereavement
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this pilot project is to evaluate the efficacy of Cymbalta for bereavement-associated depression Participating patients will be treated with Cymbalta in doses up to 60mg daily for eight 8 weeks The primary outcome measure for this study will be the 17-item Hamilton Rating Scale for Depression HRSD-17 In pursuit of this objective we will test the following hypothesis After eight weeks of open-label treatment with Cymbalta for bereavement-associated depression at least half of the participants will achieve remission as measured by a score of 7 or less on the HRSD-17
Secondary objectives of this project are
To determine the tolerability of Cymbalta treatment among patients with bereavement-associated depression as measured by adverse events and the proportion of participants who discontinue Cymbalta before completing eight weeks of study treatment
To determine the effect of Cymbalta treatment on grief in patients with bereavement-associated depression as measured by the Texas Revised Inventory of Grief and the Inventory of Complicated Grief after eight weeks of treatment compared to baseline and
To determine the effect of Cymbalta treatment on health status pain and other co-morbid symptoms in patients with bereavement-associated depression as measured by the Edmonton Symptom Assessment System and the Medical Outcomes Study 12-item Short Form Health Survey administered at Weeks 2 4 and 8 and compared to baseline
Secondary objectives of this project are
To determine the tolerability of Cymbalta treatment among patients with bereavement-associated depression as measured by adverse events and the proportion of participants who discontinue Cymbalta before completing eight weeks of study treatment
To determine the effect of Cymbalta treatment on grief in patients with bereavement-associated depression as measured by the Texas Revised Inventory of Grief and the Inventory of Complicated Grief after eight weeks of treatment compared to baseline and
To determine the effect of Cymbalta treatment on health status pain and other co-morbid symptoms in patients with bereavement-associated depression as measured by the Edmonton Symptom Assessment System and the Medical Outcomes Study 12-item Short Form Health Survey administered at Weeks 2 4 and 8 and compared to baseline
Detailed Description:
The primary objective of this pilot project is to evaluate the efficacy of Cymbalta for bereavement-associated depression Participating patients will be treated with Cymbalta in doses up to 60mg daily for eight 8 weeks The primary outcome measure for this study will be the 17-item Hamilton Rating Scale for Depression HRSD-17 In pursuit of this objective we will test the following hypothesis After eight weeks of open-label treatment with Cymbalta for bereavement-associated depression at least half of the participants will achieve remission as measured by a score of 7 or less on the HRSD-17
Secondary objectives of this project are
To determine the tolerability of Cymbalta treatment among patients with bereavement-associated depression as measured by adverse events and the proportion of participants who discontinue Cymbalta before completing eight weeks of study treatment
To determine the effect of Cymbalta treatment on grief in patients with bereavement-associated depression as measured by the Texas Revised Inventory of Grief and the Inventory of Complicated Grief after eight weeks of treatment compared to baseline and
To determine the effect of Cymbalta treatment on health status pain and other co-morbid symptoms in patients with bereavement-associated depression as measured by the Edmonton Symptom Assessment System and the Medical Outcomes Study 12-item Short Form Health Survey administered at Weeks 2 4 and 8 and compared to baseline
This pilot study is an eight-week open-label clinical antidepressant treatment trial using Cymbalta duloxetine hydrochloride in doses between 20mg and 60mg daily for patients with co-morbid depression and bereavement Twenty 20 patients who have sustained the loss of a first-degree relative spouse child parent or sibling within the past two years AND meet criteria for a major depressive episode at the time of screening will be recruited for participation in this study Patients who tolerate and respond to Cymbalta treatment will be offered maintenance therapy with Cymbalta for up to one year at the effective dose We expect that Cymbalta treatment will be associated with substantial remission and response rates as measured by HRSD-17 scores Similarly we expect substantial mean reductions in measures of grief and bereavement with improvements in measures of pain symptom burden and functional status
Secondary objectives of this project are
To determine the tolerability of Cymbalta treatment among patients with bereavement-associated depression as measured by adverse events and the proportion of participants who discontinue Cymbalta before completing eight weeks of study treatment
To determine the effect of Cymbalta treatment on grief in patients with bereavement-associated depression as measured by the Texas Revised Inventory of Grief and the Inventory of Complicated Grief after eight weeks of treatment compared to baseline and
To determine the effect of Cymbalta treatment on health status pain and other co-morbid symptoms in patients with bereavement-associated depression as measured by the Edmonton Symptom Assessment System and the Medical Outcomes Study 12-item Short Form Health Survey administered at Weeks 2 4 and 8 and compared to baseline
This pilot study is an eight-week open-label clinical antidepressant treatment trial using Cymbalta duloxetine hydrochloride in doses between 20mg and 60mg daily for patients with co-morbid depression and bereavement Twenty 20 patients who have sustained the loss of a first-degree relative spouse child parent or sibling within the past two years AND meet criteria for a major depressive episode at the time of screening will be recruited for participation in this study Patients who tolerate and respond to Cymbalta treatment will be offered maintenance therapy with Cymbalta for up to one year at the effective dose We expect that Cymbalta treatment will be associated with substantial remission and response rates as measured by HRSD-17 scores Similarly we expect substantial mean reductions in measures of grief and bereavement with improvements in measures of pain symptom burden and functional status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None